(a) The Department of State Health Services (department) shall compile and maintain a list of needleless system devices and sharps devices with engineered sharps injury protection that are available in the commercial marketplace and registered with the department to assist governmental units to comply with this chapter.
(b) Each needleless system device or sharps device with engineered sharps injury protection that is the subject of the department's device registration application shall be in conformance with all applicable premarket notification or premarket approval requirements established by the U.S. Food and Drug Administration (FDA) unless otherwise exempted from such requirements.
(c) Each device manufacturer who manufactures a needleless system device or sharps device with engineered sharps injury protection and who desires to register the device for the first time with the department shall apply for registration in accordance with the procedures found in §96.303 of this title (relating to Registration Procedures).
(d) If a device manufacturer introduces more than one needleless system device or sharps device with engineered sharps injury protection into commerce, the manufacturer shall register each device separately in order for the device to be included on a list maintained by the department.
(e) Each sharps device with engineered sharps injury protection that is the subject of the department's device registration application shall contain physical attributes consistent with those recognized as effective for engineered sharps injury protection, as defined in §96.101(9) of this title (relating to Definitions).
(f) The department may accept reports from authorities in other jurisdictions, including the FDA, to determine the extent of compliance with these sections and with the provisions of Health and Safety Code, Chapter 81, Subchapter H.
(g) The department shall register a needleless system device or sharps device with engineered sharps injury protection that meets the requirements of these sections.
(h) Registration of a needleless system device or sharps device with engineered sharps injury protection by the department does not constitute an endorsement or recommendation of such device.
(i) Registration certificates shall not be transferable from one device to another or from one device name to another. Any request for transfer of registration due to a change in ownership shall be made pursuant to the requirements in subsection (l) of this section.
(j) All device registration certificates shall expire two years from the date of issuance.
(k) Renewal of registration.
  (1) Upon expiration of a device registration, the registration may be renewed by filing an application for renewal on a form prescribed by the department, accompanied by the appropriate renewal fee.
  (2) The renewal registration certificate shall be valid for two years.
  (3) The appropriate registration renewal form and renewal fee for each device should be submitted to the department not later than 30 days following the expiration date of the current device registration in order to maintain the device on the department's list of existing needleless system devices and sharps devices with engineered sharps injury protection.
  (4) The department shall renew the registration of a needleless system device or sharps device with engineered sharps injury protection following receipt of the appropriate renewal form and renewal fee.
(l) The device manufacturer shall notify the department in writing of any change that would render the information required in the initial registration application no longer accurate. Upon receipt of a written notification involving a change, the department may update the information contained in its list of needleless system devices and sharps devices with engineered sharps injury protection in order to reflect the change.

Source Note: The provisions of this §96.302 adopted to be effective August 16, 2000, 25 TexReg 7704; amended to be effective July 23, 2006, 31 TexReg 5626